Gastric access port

ABSTRACT

An improved mechanism for attaching a feeding tube to a feeding delivery system is presented. The feeding delivery system is attached to an elongated connecting member that is pivotally attached to a bolster. After attachment, the elongated connecting member is rotated to engage another tube at the base of the pivot. Before pivoting, the passageway is blocked by the interference of the elongated connecting member. As the elongated connecting member is rotated, the conduit system aligns and becomes a passageway to and from the stomach. The device provides a three part rigid plastic fit that does not wear out over a number of uses. The device prevents splash events, which occur when a feeding adapter is opened or when the adapter or valve is forced open by a cough or gastric pressure build up.

The present application is a continuation of U.S. patent applicationSer. No. 09/929,913, now U.S. Pat. No. 6,872,189 filed Aug. 15, 2001,which is incorporated herein by reference, said patent claims claimingpriority of U.S. Provisional Patent Application No. 60/225,530, whichwas filed Aug. 15, 2000.

FIELD OF THE INVENTION

This invention relates to devices and methods for feeding throughgastrostomy feeding or access ports.

BACKGROUND OF THE INVENTION

Gastrostomy feeding devices connect the stomach to the exterior of thebody through a stoma site. These devices are inserted and left in forthe period of time that access to the stomach is needed, and are used asa conduit for feeding, decompression, delivery of medications, andsuctioning of fluids. Gastrostomy feeding ports may rise just above theskin level, or they may be an extended tube-like structure with adapterson the exterior end. In either case, an external bolster is used to holdthe tube in place to prevent slippage of the external portion of thetube into the stomach.

Bolsters in the prior art not only provide a mechanism to hold the tubeto prevent tube slippage, but also in the tubes that rise just slightlyabove the skin, these bolsters are charged with connecting to thefeeding delivery sets, or syringes used to access the gastrostomy. Inthis case, a part of the bolster must connect the lumen that traversesthe stoma into the stomach with the feeding set or syringe. When thisconnection is opened, reflux of gastric contents is likely.

Prevention of the leakage of gastric contents and the control of gastricpressures in an acidic environment has become a significant designchallenge. Materials must be resilient, soft and resealable over time.Unfortunately, many of the gastrostomy feeding port valves or mechanismsfor reflux prevention have failed over time, especially after repeateduses.

Valves have been used as a mechanism to block the unwanted flow ofgastric contents outward. The prior art includes check valves, such asthose available commercially by Novartis under Russo, U.S. Pat. No.4,944,732. This product offers a replacement valve which may be screwedinto place. The Button, another commercially available device, offers anexternal rubber flip cap and a tongue valve placed in the stomach end ofthe communicating lumen. Over time, both the rubber flip cap and thetongue valve become embrittled, and will fail to function.

Copenhaver, et al. U.S. Pat. No. 5,720,734, commercially available asthe Passport from Wilson-Cook Medical, Inc., discusses an “s” slitvalve, which lies under compression in a rigid plastic lumen. Because itis a rubber valve, it is fraught with the same embrittlement issues,especially after being violated multiple times per day over a longperiod.

Prior art devices are formed of rigid plastic and fit only feedingdelivery set tips and use an adapter to fit the bolus syringe tips, orhave been soft rubber or plastic and subject to breakage upon repeatedusage. There is a need for a long term indwelling gastrostomy feedingport which does not utilize a soft rubber valve system or soft rubberflip caps, but which serves to control flow to and from the stomach.This required device eliminates the need for rubber valves and rubberflip caps.

SUMMARY OF THE INVENTION

A connecting member is housed within a bolster of rigid or soft plasticor rubber. The connecting member pivots about a point which is locatedat one end of the connecting member. A lumen is connected to the stomachdownstream of the pivot point. The lumen is closed when the connectingmember is closed and inactive. In the closed or inactive position, theconnecting member is substantially perpendicular to the lumen connectingthe stomach. The connecting member in the inactive state blocks the flowof the lumen by physically obstructing the flow path.

Before activating the connecting member, the feeding delivery set orsyringe is placed into the lumen of the connecting member. This lumenengages the tip of the feeding delivery set tip or syringe as it is thematching taper and provides a plastic-to-plastic fit. To activate, theconnecting member is pivoted substantially 90 degrees and the lumen isopen. Once the desired procedure of delivering or withdrawing solutionsis accomplished, the connecting member is pivoted back into horizontalposition and renders the lumen inactive.

By one aspect of the present invention, there is provided a long-termindwelling catheter with an improved anti-reflux mechanism, whichremains sealed over multiple uses. The improved anti-reflux mechanism isuseful to any feeding gastrostomy system that is left indwelling in apatient and used repeatedly on a daily basis.

The pivoting connecting member may be formed of rigid plastic materialshoused in a matrix of a rigid or a resilient bolster connecting thelumen of the feeding tube. The pivoting connecting member is inactiveand blocking the lumen of the feeding tube when it is at rest. Uponconnection to a syringe or feeding delivery set, the pivoting connectingmember is rotated 90 degrees until it is aligned with the feeding lumen.Additional embodiments include the plastic to plastic fit and taper ofthe pivoting connecting lumen to the feeding delivery sets and to thefeeding bolus syringe tip, thus avoiding the use of adapters forengagement.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the device showing the bottom of thebolster in which the pivoting connecting tube is housed.

FIG. 2 is a perspective view of the device showing the top of bolster inwhich the pivoting connecting tube is housed.

FIG. 3 is an exploded view showing the device with a novel connectingapparatus.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawing Figures, FIGS. 1 and 2 show an anchoringdevice such as bolster 2 which forms a housing for a connecting member4. The bolster may be formed of various materials. It is preferred thatthe bolster be formed of rigid or soft plastic material, or of rubber.The bolster should be formed of materials which are easy to clean, donot readily oxidize, and do not promote the growth of bacteria.

As shown in FIG. 2, the connecting member is housed within the bolster.One end 8 of the connecting member is preferred to extend beyond thebolster, so that the bolster may be connected to a feeding tube, asyringe or other delivery device, without the necessity of pivoting orrotating the connecting member, so that the device remains in the closedposition during connection.

The opposite end of the connecting member is attached to the bolster bymeans of a pivotal connection. Accordingly, the connecting member may beconnected or rotated relative to the bolster. When the connecting memberis in the position shown in FIG. 2, the device is in the closed, orinactive position. That is, access to the stomach through the lumen isblocked by the connecting member.

The lumen is connected to the bottom of the bolster. FIG. 2. When theconnecting member is rotated 90°, so that it is in the position as shownin FIG. 3, a direct access or opening is available from an upper end ofthe connecting end, through the connecting member, and into the bolster,through the lower opening of the bolster, and into the lumen. When theconnecting member is rotated to the position shown in FIG. 2, theconnecting member blocks the opening to the bolster, also blockingaccess to the lumen.

As shown, a channel is formed in the bolster. The connecting member isheld within the channel, so that the connecting member can be fullyrotated 90°. The end of the connecting member extends beyond the end ofthe bolster. Since the sides of the connecting member are solid andnon-porous, as the connecting member is rotated to the position as shownin FIG. 2, it blocks the opening to the bolster, preventing access tothe lumen.

In use, the device is connected to a lumen. A novel method and devicefor connecting the lumen is discussed hereinafter.

The device is connected to the lumen at the bottom opening of thebolster; an upper end of the connecting member is connected to a feedingtube, syringe, or similar supply conduit. The connecting member isformed to accept appropriate connections. After the feeding tube,syringe or other conduit is connected, the connecting member is rotatedto the position shown in FIG. 3. The device is now in the open or activeposition, with an unobstructed conduit available from the supply sourcethrough the device and into the lumen. At the end of the feeding processor other procedure, the connecting member is rotated from the positionshown in FIG. 3, to the position shown in FIG. 2, and the supply conduitis removed. The device remains in the position as shown in FIG. 2 untilaccess to the stomach is again required for feeding, administeringmedicines, evacuating the stomach, or the performance of otherprocedures.

The bolster is designed to lie flat against the stomach, so that it isnot subject to hooking or snagging or other interaction which couldpresent a hazard to the patient. Similarly, the connecting member isretained within a channel 10 in the bolster, so that the connectingmember is not subject to hooking or snagging.

A novel means of connecting the lumen is also presented. Most tubes orconduits used with feeding tubes in the prior art are formed ofsilicone. Silicone is an appropriate material from which form the lumenwhich is used as the feeding tube. However, certain problems are alsopresent when silicone tubes are used. Silicone tubes tend to have a lowcoefficient of friction, and are particularly slippery when operating inthe wet conditions normally encountered with feeding tubes. Siliconetubes will tend to slip back into the stomach, which can presentsignificant problems for the patient. The tube may not completely slipinto the stomach, but it may slip far enough so that the stomach acidsare introduced into the body, which can cause sepsis and other problems.

In the present invention, a collar 12 is formed having an insidediameter which is approximately the same size as, or perhaps or slightlysmaller than, the outside diameter of the resilient tube 14 which isused as the feeding tube. The fit should be such that the collar can beforced onto the tube by manual pressure, but it will not readily slide.The diameter is also such that the collar does not compress to interferewith the flow of material through the tube.

The collar should either have threads, or a series of peaks and valleys,or similar irregular shape formed on the inside diameter. For example, anut of the appropriate inside diameter could be used. Threaded,stainless steel nuts are appropriate candidates for forming the collar.As shown in FIG. 3, the fitting 16 on the bottom of the device has malethreads. The outside diameter of this fitting is preferred to beslightly larger than the inside diameter of the lumen, so that the malethreads are engaged with the lumen, and the fitting is advanced bythreading it into the lumen.

The male threads are used as a mandrel to force the tubing into thethreads or other peaks and valleys which are formed in the collar.Threads of the fitting of the device do not engage the threads of thecollar. It is not necessary that the collar be threaded per se, it isonly necessary that the collar have an irregular surface such as peaksand valleys which will engage and grip the silicone, or other materialfrom which the lumen is formed, when forced against the collar by themale threads. Accordingly, the tubing which forms the lumen does nothold the fitting in place by the engagement of the threads, but rather,it is held in place by the forcing of the lumen material against theinside of the collar.

If a longer tube is desired, such as in nursing home use, the longertube, may be attached to the connecting member of the bolster. If thetube clogs, it may be removed and replaced. In the prior art, cloggingis relieved by replacing the entire tube in the endoscopy suite.

The connecting member may be removable. Removal of the connecting memberfacilitates insertion of laparoscopic or endoscopic instruments. Gastricor esophageal therapy may be performed, and the pivotal connectorsubsequently replaced. The feeding tube acts as a trocar for laproscopicsurgery requiring gastric access.

1. A device for insertion into a body cavity to selectively transportfluids to and from said body cavity, comprising: a tube comprising alumen which traverses from an interior of said body cavity to anexterior of said body cavity, said tube having a first end and a secondend, said second end having an enlargement for anchoring said second endof said tube within a body cavity; an anchoring device that is attachedto said first end of said tube, wherein said anchoring device comprisesa housing, and an elongated connector member having a lumen extendingfrom a first end of said elongated connector member to a second end ofsaid elongated connector member, said elongated connector member beingpivotally mounted to said housing, wherein said elongated connectingmember is pivoted to align to permit movement between a first positionin which said elongated connector member is positioned substantiallyparallel to said tube to align said lumen of said elongated connectingmember with said lumen of said tube to facilitate permit transportationof fluids to and from said body cavity, and said elongated connectingmember is alternately pivoted to and a second position in which saidelongated connector member is positioned substantially perpendicular tosaid tube to prevent alignment of said lumen of said elongatedconnecting member with said lumen of said tube holding mechanism toprevent transportation of fluids to and from said body cavity.
 2. Adevice for insertion into a body cavity to selectively transport fluidsto and from said body cavity as described in claim 1, wherein, when saidelongated connecting member is alternately pivoted to prevent alignmentof said lumen of said elongated connecting member with said lumen ofsaid tube holding mechanism, said elongated connecting member covers anopening of said lumen of said tube.
 3. A device for insertion into abody cavity to selectively transport fluids to and from said body cavityas described in claim 2, wherein, when said elongated connecting memberis alternately pivoted to prevent alignment of said lumen of saidelongated connecting member with said lumen of said tube holdingmechanism and said elongated connecting member covers an opening of saidlumen of said tube, said elongated connecting member extends beyond anend of said housing.
 4. A device for insertion into a body cavity toselectively transport fluids to and from said body cavity as describedin claim 1, wherein, when said elongated connecting member isalternately pivoted to prevent alignment of said lumen of said elongatedconnecting member with said lumen of said tube holding mechanism, saidelongated connecting member extends beyond an end of said housing.
 5. Adevice for insertion into a body cavity to selectively transport fluidsto and from said body cavity, comprising: a tube comprising a lumenwhich traverses from an interior of said body cavity to an exterior ofsaid body cavity, wherein said tube is a silicone tube, said tube havinga first end and a second end, said second end having an enlargement foranchoring said second end of said tube within a body cavity; ananchoring device that is attached to said first end of said tube,wherein said anchoring device comprises a housing and an elongatedconnector member having a lumen extending from a first end of saidelongated connector member to a second end of said elongated connectormember, said housing being shaped to lie flat against a patient, saidelongated connector member being pivotally mounted to said housing topermit movement between a first position in which said elongatedconnector member is positioned substantially parallel to said tube toalign said lumen of said elongated connecting member with said lumen ofsaid tube to permit transportation of fluids to and from said bodycavity and a second position in which said elongated connector member ispositioned substantially perpendicular to said tube to prevent alignmentof said lumen of said elongated connecting member with said lumen ofsaid tube to prevent transportation of fluids to and from said bodycavity.
 6. The device as claimed in claim 5 wherein said tube is afeeding tube.
 7. The device as claimed in claim 6 wherein said feedingtube is a gastrostomy feeding tube.
 8. The device as claimed 5, wherein,when said elongated connecting member is positioned to prevent alignmentof said lumen of said elongated connecting member with said lumen ofsaid tube, said elongated connecting member extends beyond an end ofsaid housing.
 9. The device as claimed in claim 5, wherein said housingof said anchoring device comprises a channel therein, and wherein, whensaid elongated connecting member is positioned to prevent alignment ofsaid lumen of said elongated connecting member with said lumen of saidtube, said elongated connecting member rests in said channel and extendsbeyond an end of said channel.
 10. A device for insertion into a bodycavity to selectively transport fluids to and from said body cavity,comprising: a tube comprising a lumen which traverses from an interiorof said body cavity to an exterior of said body cavity; an anchoringdevice that is attached to said tube, wherein said anchoring devicecomprises a housing and an elongated connector member having a lumenextending from a first end of said elongated connector member to asecond end of said elongated connector member, said housing being shapedto lie flat against a patient, said elongated connector member beingpivotally mounted to said housing to permit movement between a firstposition in which said elongated connector member is positionedsubstantially parallel to said tube to align said lumen of saidelongated connecting member with said lumen of said tube to permittransportation of fluids to and from said body cavity and a secondposition in which said elongated connector member is positionedsubstantially perpendicular to said tube to prevent alignment of saidlumen of said elongated connecting member with said lumen of said tubeto prevent transportation of fluids to and from said body cavity,wherein said tube has a first end and a second end, said second endhaving an enlargement for anchoring said second end of said tube withina body cavity, said anchoring device being attached to said first end ofsaid tube.